GMP Downstream Processing Manager

Hobson Prior are looking for a GMP Downstream Processing Manager to join a top biotechnology organisation on a permanent basis in Stevenage. Our client concentrates on developing pioneering gene therapies to enable people living with chronic diseases live a better life.

Job Responsibilities:

• You will work closely with the Director of Production in the planning and practical delivery of clinical product supply for the organisation's products.
• Managing the Downstream Production team (up-to 5 direct reports) including, identification of resource requirements, ensuring all team members are trained and competent to execute their role, professional development of team members.
• Responsible for delivering practical training for junior team members in the Downstream Production team.
• Managing technology transfer of new Downstream processes into the facility. Writing, reviewing and approving documentation required for technology transfer and working as part of a matrix team for delivering the technology transfer on time.
• Managing the technical operations in the cleanroom for practical delivery of engineering, non-clinical and clinical batches of drug substance.
• Responsible for the planning and delegation of technical tasks to DSP team members during batch manufacture.
• Hands-on execution of the manufacturing process within the cleanroom as required to support manufacture.
• Accountable for ensuring all BMRs, log-books, forms are completed by DSP team members on a daily basis to the principles of ALCOA and any deviations are raised on-time according to SOP.
• Accountable for ensuring that all required cleaning, environmental monitoring, waste removal and waste inactivation is performed by DSP team members on a daily basis according to SOPs.
• Writing, reviewing and approving documentation including SOPs, BMRs and risk assessments.
• Responsible for reviewing and approving production records prior to Quality review.
• Any other assigned tasks.

Requirements:

• Educated to degree level or equivalent in a biological or engineering science.
• A minimum of 7 years' experience working in a GMP environment with at least 3 years' experience in a leadership role.
• A minimum of 5 years hands-on experience executing Downstream manufacturing processes.
• Experienced in generating and reviewing GMP documentation and safety risk assessments.
• A good working knowledge of EU GMP.
• A good working knowledge of cleanrooms, aseptic technique and hygiene requirements for GMP manufacture.
• Ability to work in a cleanroom environment and support weekend/shift operations as required.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.